Clinical trial · Interventional
Nonpharmacological Management of Pain and Fear During Hormone Injection in Breast Cancer Patients
ShotBlocker and Helfer Technique in the Management of Pain and Fear During Hormone Injection in Patients With Breast Cancer: A Randomized Controlled Trial
NCT07406165CI-TRIAL-00103240not yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This randomized controlled study will compare the effects of the ShotBlocker device and the Helfer Skin Tap Technique on pain and fear during intramuscular hormone injections in premenopausal and postmenopausal breast cancer patients. Ninety-nine participants will be randomly assigned to three groups (ShotBlocker, Helfer, control). All injections will be administered by the same nurse using standardized procedures. Pain will be assessed with the Visual Analog Scale, and fear with the Injection Fear Scale. The study aims to identify effective nonpharmacological methods to enhance patient comfort, support treatment adherence, and improve nursing care quality.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Fear | — | UNRESOLVED | — |
| Injection Fear | — | UNRESOLVED | — |
| Injection Pain Prevention | — | UNRESOLVED | — |
| Pain Management | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ShotBlocker device | Device | — | UNRESOLVED |
| This involves rhythmic, gentle tapping with the fingertips on the skin surrounding the gluteal injection site. | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- ShotBlocker Group
- description
- Shotblocker Group: The Shotblocker device will be positioned at the gluteal injection site using aseptic techniques immediately before the administration of hormonal medications. Standard intramuscular (IM) injection protocols will be followed while the device is in situ to mitigate injection-related pain.
- interventionNames
- Device: ShotBlocker device
- type
- ACTIVE_COMPARATOR
- label
- Helfer Skin Tap Technique Group
- description
- Helfer Skin Tap Group: Rhythmic skin tapping will be performed at points near the gluteal injection site immediately before and during the procedure. Standard intramuscular (IM) injection of hormonal medications will be administered following the Helfer Skin Tap protocol to reduce procedural pain and muscle tension.
- interventionNames
- Procedure: This involves rhythmic, gentle tapping with the fingertips on the skin surrounding the gluteal injection site.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged between 18 and 65 years. * Patients diagnosed with breast cancer. * Requirement of intramuscular (IM) injection of premenopausal or postmenopausal hormonal medications as part of their prescribed treatment. * Cognitive competence to provide informed consent for the injection procedure. Intact skin integrity and normal sensory perception at the injection site (gluteal region). Exclusion Criteria: * History of chronic pain disorders, neuropathic pain syndrome, or any disease requiring regular analgesic use. * Presence of neurological or cognitive disorders that may alter pain or fear perception. * Use of analgesics within the last 24 hours (or a specific timeframe relevant to your study).
References
Publications (7)
- BACKGROUNDYaray O, Akesen B, Ocaklioglu G, Aydinli U. Validation of the Turkish version of the visual analog scale spine score in patients with spinal fractures. Acta Orthop Traumatol Turc. 2011;45(5):353-8. doi: 10.3944/AOTT.2011.2528. PMID 22033000
- BACKGROUNDAgac E, Gunes UY. Effect on pain of changing the needle prior to administering medicine intramuscularly: a randomized controlled trial. J Adv Nurs. 2011 Mar;67(3):563-8. doi: 10.1111/j.1365-2648.2010.05513.x. Epub 2010 Dec 28. PMID 21198801
- BACKGROUNDCocoman A, Murray J. Intramuscular injections: a review of best practice for mental health nurses. J Psychiatr Ment Health Nurs. 2008 Jun;15(5):424-34. doi: 10.1111/j.1365-2850.2007.01236.x. PMID 18454829
- BACKGROUNDMalkin B. Are techniques used for intramuscular injection based on research evidence? Nurs Times. 2008 Dec 16-2009 Jan 12;104(50-51):48-51. PMID 19165987
- BACKGROUNDSmall SP. Preventing sciatic nerve injury from intramuscular injections: literature review. J Adv Nurs. 2004 Aug;47(3):287-96. doi: 10.1111/j.1365-2648.2004.03092.x. PMID 15238123
- BACKGROUNDOrdu Y, Polat HT, Kucukceran K. Effects of cold needle and ShotBlocker applied in the emergency department on pain and satisfaction in intramuscular injection pain: A randomized controlled trial. Australas Emerg Care. 2025 Sep;28(3):157-162. doi: 10.1016/j.auec.2025.02.001. Epub 2025 Feb 8. PMID 39924365
- BACKGROUNDSavci C, Ozkan B, Aciksari K, Solakoglu GA. Effectiveness of Two Different Methods on the Perceived Pain and Satisfaction During Intramuscular Antibiotic Injection: ShotBlocker and Local Vibration. Clin Nurs Res. 2022 Jun;31(5):812-819. doi: 10.1177/10547738211051877. Epub 2021 Oct 11. PMID 34628979